BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL DX

    MDR report key: 1791758 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03061
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 6, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071655
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) INITIAL ANALYSIS CONFIRMED THE REPORTED NO TELEMETRY CONDITION. FURTHER ANALYSIS FOUND A HIGH CURRENT DRAIN CONDITION. THE CAUSE OF THE HIGH CURRENT DRAIN CONDITION WAS THE RESULT OF SOLDER BUMPS ON AN INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT ROUTINE FOLLOW-UP, THE DEVICE WAS FOUND TO BE "DEAD," WITH NO TELEMETRY. ADDITIONAL INFORMATION WAS LATER RECEIVED REPORTING THE PATIENT WAS NOT ABLE TO TRANSMIT VIA CARELINK ANY LONGER, SO THE PHYSICIAN WAS CONTACTED. THE PHYSICIAN TRIED TO INTERROGATE THE DEVICE, BUT IT WAS NOT POSSIBLE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT STATUS WAS REPORTED TO BE FINE FOLLOWING THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL DX IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9528 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention